Cigarette SmokingNCT01633567
Culturally Targeted & Individually Tailored Smoking Cessation Study: LGBT Smokers
A study testing Culturally Targeted Cessation Program and Non-Targeted Cessation Program in people with Cigarette Smoking, run by University of Illinois Chicago at 1 site in United States.
Trial summary
For the approximately 4.6 million LGBT persons in the U.S., smoking rates among those living in urban areas are roughly twice that of heterosexuals. Targeted interventions have shown great promise in reducing health risk behaviors across a variety of behaviors and population groups by enhancing the relevance of the… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking
- What is being tested?
- Culturally Targeted Cessation Program and Non-Targeted Cessation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self identify as lesbian, gay, bisexual, or transgender
- Age 18-65
- Current cigarette smoker
- Desire to quit smoking (self-report rating of interest in quitting)
- Relatively healthy, with no medical conditions that would adversely interact with study parameters (see exclusion criteria for specific details)
- Agree to attend behavioral counseling sessions, be randomized, and be followed-up
- Agrees to use nicotine patch and has no prior adverse reactions to patch
- Has stable residence and telephone and can provide the name of an outside household collateral family member or close friend for contact and follow-up.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Culturally Targeted and Individually Tailored Smoking Cessation Intervention for LGBT Smokers
For the approximately 4.6 million LGBT persons in the U.S., smoking rates among those living in urban areas are roughly twice that of heterosexuals. Targeted interventions have shown great promise in reducing health risk behaviors across a variety of behaviors and population groups by enhancing the relevance of the health information. The primary aim of this study is to test the efficacy of a culturally targeted group-based smoking cessation intervention (vs. a non-targeted intervention) on smoking outcomes among lesbian, gay, bisexual, and transgender (LGBT) smokers. The investigators anticipate that the culturally targeted intervention will be more effective at helping LGBT smokers to successfully stop smoking than will the non-targeted intervention.
Read the detailed description
In Phase 1 of this study we used focus groups to establish the cultural appropriateness and acceptability of the targeted elements of the intervention for the LGBT population. For Phase 2 of this study, we seek to enroll 400 participants in a randomized controlled trial of the targeted intervention vs. a non-targeted, comparison condition. Both conditions will consist of group counseling sessions combined with nicotine replacement therapy and peer support. We expect that quit rates, stage of readiness, perceived benefits, self-efficacy, and treatment adherence will be higher among those who received the targeted intervention than those in the non-targeted intervention. Furthermore, we expect that a stronger LGBT cultural identification and salience of that identity will be associated with more satisfaction and adherence to the targeted intervention.
- Conditions
- Cigarette Smoking
- Being tested
- Culturally Targeted Cessation Program, Non-Targeted Cessation Program
- Keywords
- Smoking Cessation, Cigarette Smoking, Tobacco, LGBT, LGBTQ
- Medical subject headings
- Cigarette Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally Targeted Cessation ProgramBehavioural
The culturally targeted version of the behavioral counseling intervention will consist of six group-based smoking cessation counseling sessions. Each smoking cessation therapy session will last approximately 90 minutes and will begin two weeks before the quit date. In addition, participants will be provided nicotine replacement therapy and peer support sessions will occur between the group sessions.
Non-Targeted Cessation ProgramBehavioural
Behavioral counseling intervention will consist of six group-based smoking cessation counseling sessions. Each smoking cessation therapy session will last approximately 90 minutes and will begin two weeks before the quit date. In addition, participants will be provided nicotine replacement therapy and peer support sessions will occur between the group sessions.
| Study group | Role | What they receive |
|---|---|---|
| Culturally Targeted Cessation Program | Experimental | The culturally targeted program will include the same cognitive and behavioral approaches and smoking education content that is used in the standard program. As such, we will maintain the integrity of the core program. However, cultural targeting of that program has been informed by local LGBT focus group input and testing, the available literature on LGBT smoking rates and behaviors, feedback from a panel of LGBT health experts, and data collected as part of a previous study. Receives: Behavioral: Culturally Targeted Cessation Program |
| Non-Targeted Cessation Program | Active comparator | Non-culturally targeted program with cognitive and behavioral approaches and smoking education content. Receives: Behavioral: Non-Targeted Cessation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-Day Point Prevalence Smoking Quit Rates 1 Month Post Quit Date
7-Day point prevalence smoking quit rates will serve as the main outcome measure and will be obtained from Time Line Follow-Back (TLFB) interviews.
Measured: Assessed 1 month after quit date
7-Day Point Prevalence Smoking Quit Rates 3 Months Post Quit Date
7-Day point prevalence smoking quit rates will serve as the main outcome measure and will be obtained from Time Line Follow-Back (TLFB) interviews.
Measured: Assessed 3 months after quit date
7-Day Point Prevalence Smoking Quit Rates 6 Months Post Quit Date
7-Day point prevalence smoking quit rates will serve as the main outcome measure and will be obtained from Time Line Follow-Back (TLFB) interviews.
Measured: Assessed 6 months after quit date
7-Day Point Prevalence Smoking Quit Rates 12 Months Post Quit Date
7-Day point prevalence smoking quit rates will serve as the main outcome measure and will be obtained from Time Line Follow-Back (TLFB) interviews.
Measured: Assessed 12 months after quit date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2012 (estimated)
- Study startMay 2012
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Cancer Institute (NCI), Howard Brown Health Center
- Responsible party
- Principal investigator, Alicia Matthews, University of Illinois Chicago
- Investigators
- Alicia K Matthews, Ph.D., Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01633567
- Sponsor's protocol ID
- 2010-0538
- Other IDs
- R01DA023935
- Status last verified
- May 2017
- First submitted
- 30 May 2012
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Matthews AK, McConnell EA, Li CC, Vargas MC, King A. Design of a comparative effectiveness evaluation of a culturally tailored versus standard community-based smoking cessation treatment program for LGBT smokers. BMC Psychol. 2014 May 30;2(1):12. doi: 10.1186/2050-7283-2-12. eCollection 2014.
PubMed 25566383
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Culturally Targeted and Individually Tailored Smoking Cessation Intervention for LGBT Smokers
- ClinicalTrials.gov ID
- NCT01633567
- Acronym / sponsor ID
- 2010-0538
- Conditions
- Cigarette Smoking
- Keywords
- Smoking Cessation, Cigarette Smoking, Tobacco, LGBT, LGBTQ
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Cancer Institute (NCI), Howard Brown Health Center
- Study start
- May 2012 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 4 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
For the approximately 4.6 million LGBT persons in the U.S., smoking rates among those living in urban areas are roughly twice that of heterosexuals. Targeted interventions have shown great promise in reducing health risk behaviors across a variety of behaviors and population groups by enhancing the relevance of the health information. The primary aim of this study is to test the efficacy of a culturally targeted group-based smoking cessation intervention (vs. a non-targeted intervention) on smoking outcomes among lesbian, gay, bisexual, and transgender (LGBT) smokers. The investigators anticipate that the culturally targeted intervention will be more effective at helping LGBT smokers to successfully stop smoking than will the non-targeted intervention.
Detailed description
In Phase 1 of this study we used focus groups to establish the cultural appropriateness and acceptability of the targeted elements of the intervention for the LGBT population. For Phase 2 of this study, we seek to enroll 400 participants in a randomized controlled trial of the targeted intervention vs. a non-targeted, comparison condition. Both conditions will consist of group counseling sessions combined with nicotine replacement therapy and peer support. We expect that quit rates, stage of readiness, perceived benefits, self-efficacy, and treatment adherence will be higher among those who received the targeted intervention than those in the non-targeted intervention. Furthermore, we expect that a stronger LGBT cultural identification and salience of that identity will be associated with more satisfaction and adherence to the targeted intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Culturally Targeted Cessation Program | Experimental | Behavioral: Culturally Targeted Cessation ProgramThe culturally targeted program will include the same cognitive and behavioral approaches and smoking education content that is used in the standard program. As such, we will maintain the integrity of the core program. However, cultural targeting of that program has been informed by local LGBT focus group input and testing, the available literature on LGBT smoking rates and behaviors, feedback from a panel of LGBT health experts, and data collected as part of a previous study. |
| Non-Targeted Cessation Program | Active comparator | Behavioral: Non-Targeted Cessation ProgramNon-culturally targeted program with cognitive and behavioral approaches and smoking education content. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Self identify as lesbian, gay, bisexual, or transgender
- Age 18-65
- Current cigarette smoker
- Desire to quit smoking (self-report rating of interest in quitting)
- Relatively healthy, with no medical conditions that would adversely interact with study parameters (see exclusion criteria for specific details)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Culturally Targeted Cessation ProgramThe culturally targeted version of the behavioral counseling intervention will consist of six group-based smoking cessation counseling sessions. Each smoking cessation therapy session will last approximately 90 minutes and will begin two weeks before the quit date. In addition, participants will be provided nicotine replacement therapy and peer support sessions will occur between the group sessions. | Behavioural | Culturally Targeted Cessation Program |
| Non-Targeted Cessation ProgramBehavioral counseling intervention will consist of six group-based smoking cessation counseling sessions. Each smoking cessation therapy session will last approximately 90 minutes and will begin two weeks before the quit date. In addition, participants will be provided nicotine replacement therapy and peer support sessions will occur between the group sessions. | Behavioural | Non-Targeted Cessation Program |
Primary outcome
7-Day Point Prevalence Smoking Quit Rates 1 Month Post Quit Date
Time frame: Assessed 1 month after quit date
7-Day point prevalence smoking quit rates will serve as the main outcome measure and will be obtained from Time Line Follow-Back (TLFB) interviews.
7-Day Point Prevalence Smoking Quit Rates 3 Months Post Quit Date
Time frame: Assessed 3 months after quit date
7-Day point prevalence smoking quit rates will serve as the main outcome measure and will be obtained from Time Line Follow-Back (TLFB) interviews.
7-Day Point Prevalence Smoking Quit Rates 6 Months Post Quit Date
Time frame: Assessed 6 months after quit date
7-Day point prevalence smoking quit rates will serve as the main outcome measure and will be obtained from Time Line Follow-Back (TLFB) interviews.
7-Day Point Prevalence Smoking Quit Rates 12 Months Post Quit Date
Time frame: Assessed 12 months after quit date
7-Day point prevalence smoking quit rates will serve as the main outcome measure and will be obtained from Time Line Follow-Back (TLFB) interviews.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
- Derived from this study: PubMed 25566383Matthews AK, McConnell EA, Li CC, Vargas MC, King A. Design of a comparative effectiveness evaluation of a culturally tailored versus standard community-based smoking cessation treatment program for LGBT smokers. BMC Psychol. 2014 May 30;2(1):12. doi: 10.1186/2050-7283-2-12. eCollection 2014.
- Research Partner AgencyLink provided by the sponsor.
- University of Illinois at Chicago WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alicia K Matthews, Ph.D. principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally Targeted Cessation Program and Non-Targeted Cessation Program in people with Cigarette Smoking, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-Day Point Prevalence Smoking Quit Rates 1 Month Post Quit Date (time frame: Assessed 1 month after quit date). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01633567, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2017.